Actively Recruiting

Phase Not Applicable
Age: 16Years - 30Years
All Genders
NCT05116514

Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-12-31

256

Participants Needed

6

Research Sites

370 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding. The intervention of case managers according to the recommendations of good practices will make it possible to propose the fundamental principles of early intervention to young patients and their families on a large scale throughout the territory, namely: personalized and proactive accompaniment, psycho-education of the pathology and treatments, involvement and support of the families, and support for socio-professional reintegration

CONDITIONS

Official Title

Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.

Who Can Participate

Age: 16Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The patient or their close relative must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is available for a 3-year follow-up
  • Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by presence of positive psychotic symptoms evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion
  • Patient has never taken neuroleptic treatment aimed at antipsychotic use prior to current episode treatment
  • Patient has a disorder meeting DSM 5 criteria including delusional disorder, brief psychotic disorder >7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder >7 days, other schizophrenic spectrum or psychotic disorders, bipolar I or II disorder with psychotic features, or major depressive disorder with psychotic features
  • Inclusion should be within the first 3 months of care for first episode psychosis
  • Psychotic symptomatology may still be present or in remission at inclusion
Not Eligible

You will not qualify if you...

  • Participating in another category I interventional study or within an exclusion period from a prior study
  • Refusal to sign consent by patient or parent (if minor)
  • Inability to provide informed information to the subject
  • Patient under safeguard of justice or state guardianship
  • Patient has IQ less than or equal to 55
  • First psychotic episode linked to a psychotic problem triggered by medication or other medical condition
  • Patient is pregnant or breastfeeding

AI-Screening

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Trial Site Locations

Total: 6 locations

1

CHU de TOULOUSE

Toulouse, Choisir Une Région, France, 31

Not Yet Recruiting

2

CH Saint Marie Clermont-Ferrand

Clermont-Ferrand, France

Not Yet Recruiting

3

CHU de Montpellier

Montpellier, France

Actively Recruiting

4

CHU Nice

Nice, France

Not Yet Recruiting

5

CHU de Nîmes

Nîmes, France

Actively Recruiting

6

Centre Hospitalier Léon-Jean Grégory

Thuir, France

Actively Recruiting

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Research Team

A

Aurélie Schandrin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode. | DecenTrialz